Lexapro (Escitalopram Oxalate) - Summary

LEXAPRO SUMMARY

LEXAPRO® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram.

LEXAPRO (escitalopram) is indicated for the following:

MAJOR DEPRESSIVE DISORDER

LEXAPRO (escitalopram) is indicated for the treatment of major depressive disorder.

The efficacy of LEXAPRO in the treatment of major depressive disorder was established in three, 8-week, placebo-controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The efficacy of LEXAPRO in hospitalized patients with major depressive disorders has not been adequately studied.

The efficacy of LEXAPRO in maintaining a response, in patients with major depressive disorder who responded during an 8-week, acute-treatment phase while taking LEXAPRO and were then observed for relapse during a period of up to 36 weeks, was demonstrated in a placebo-controlled trial (see Clinical Efficacy Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use LEXAPRO for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

GENERALIZED ANXIETY DISORDER

LEXAPRO is indicated for the treatment of Generalized Anxiety Disorder (GAD). The efficacy of LEXAPRO was established in three, 8-week, placebo-controlled trials in patients with GAD (see CLINICAL PHARMACOLOGY).

Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.

The efficacy of LEXAPRO in the long-term treatment of GAD, that is, for more than 8 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use LEXAPRO for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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NEWS HIGHLIGHTS

Media Articles Related to Lexapro (Escitalopram)

Lexapro Approved for Adolescent Depression
Source: MedicineNet escitalopram Specialty [2009.03.23]
Title: Lexapro Approved for Adolescent Depression
Category: Health News
Created: 3/21/2009 2:00:00 AM
Last Editorial Review: 3/23/2009

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Published Studies Related to Lexapro (Escitalopram)

Impact of CYP2C19 phenotypes on escitalopram metabolism and an evaluation of pupillometry as a serotonergic biomarker. [2009.09]
PURPOSE: To investigate the impact of cytochrome P450 2C19 (CYP2C19) phenotypes on escitalopram metabolism and to evaluate pupillometry as a serotonergic biomarker... CONCLUSIONS: The CYP2C19 polymorphism affects escitalopram metabolism, but the difference does not justify dose adjustment. The puzzling results from pupillometry can be due to interplay between a central and a local serotonergic effect. Based on these results, pupillometry can not be recommended as a serotonergic biomarker.

Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. [2009.07]
CONCLUSIONS: In this study, escitalopram was effective and well tolerated in the treatment of depressed adolescents.

Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD). [2009.04.07]
BACKGROUND: The prevalence of depression in patients with acute coronary syndrome, i.e... TRIAL REGISTRATION: http://www.ClinicalTrials.gov.

Effects of escitalopram on anxiety and respiratory responses to carbon dioxide inhalation in subjects at high risk for panic disorder: a placebo-controlled, crossover study. [2009.04]
BACKGROUND: Individuals with panic disorder and those at high risk for panic disorder due to a positive family history seem to have elevated sensitivities to the panicogenic effects of carbon dioxide (CO2) inhalation as well as abnormal ventilatory responses to low doses of CO2 exposure. Many reports have described a reduction in anxiety responses in individuals with panic disorder after a brief treatment with a variety of medications effective in the treatment of panic disorder, but few of these have used placebo control... CONCLUSIONS: Escitalopram did not produce greater changes than placebo in panic responses or in ventilatory abnormalities seen during CO2 exposure. Future studies concerning the effects of antidepressants on responses to CO2 challenge should use a placebo-controlled design.

Superiority of escitalopram to paroxetine in the treatment of depression. [2009.04]
Post-hoc pooled analysis of data from two 6-month randomised controlled trials in patients with major depressive disorder (MDD) revealed superior efficacy and tolerability of escitalopram when compared with paroxetine. Escitalopram (n=394) produced a significantly (p<0.01) greater mean treatment difference of 2.0 points in primary endpoints, judged using the Montgomery-Asberg Depression Rating Scale (MADRS) total score, compared with paroxetine (n=383)...

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Clinical Trials Related to Lexapro (Escitalopram)

Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features [Completed]
Aims of Study:

The aims of this study are 1) to examine the clinical utility of escitalopram in patients with major depression with atypical features; 2) to evaluate the tolerability of escitalopram in major depression with atypical features.

Study hypothesis and objectives. This study is proposed as an open-label study to gather pilot data to examine whether escitalopram has clinical utility in the treatment of major depression with atypical features. Because of the exploratory nature of the design, no specific study hypotheses can be generated regarding efficacy of the drug. Our primary hypothesis is that the effect size of escitalopram in atypical depression will be similar to the effect size of escitalopram in major depression, its FDA approved indication.

Food Study of Escitalopram Oxalate Tablets 20 mg to Lexapro® Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's escitalopram oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administered under fed conditions.

Fasting Study of Escitalopram Oxalate Tablets 20 mg and Lexapro® Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's escitalopram oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administered under fasting conditions.

Efficacy of Escitalopram in the Treatment of Internet Addiction [Completed]
The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and effective in treating problematic internet use.

Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-Life Depression [Active, not recruiting]
This study will determine whether adding interpersonal psychotherapy to treatment with the antidepressant escitalopram will be more effective in reducing symptoms of depression than antidepressant medication alone.

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PATIENT REVIEWS / RATINGS / COMMENTS

Lexapro review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		depression/anxiety
Dosage & duration:		10mg daily taken daily for the period of two months and continuingto use it
Other conditions:		frustrated/short temper/mood swings
Other drugs taken:		none
		Reported Results
Benefits:		better outlook on life in general, less anxious, easier to deal with everything, a difference of night and day
Side effects:		during the initial dose(first week to ten days) a bit of nausea,strange sensation in teeth and my head felt a little odd
Comments:		I am happily married with two children, ages three and five. For years I cried everyday, freaked out at the drop of a hat, yelled all the time, had no self esteem and sometimes thought I could not go on. After two weeks of taking Lexapro I am a completely different person. I have not cried once after the first week of being treated. I love myself and my kids. All the menial tasks that I felt so difficult before, I now do with a great sense of ease. My friends and family notice a huge change in me. I couldn't be happier.

Lexapro review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		depression/anxiety
Dosage & duration:		20mg per day taken daily for the period of about 6 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Lexapro worked very well to make me feel better, less anxious and unhappy.
Side effects:		I gained ten pounds in the few months that I took this medicine.
Comments:		I've taken several anti-depressants over the years trying to find something with the least side effects for me. Paxil caused my jaw to always clench, Prozac caused heart flutters. My doctor was very insistant that Lexapro was not the cause of my weight gain. However, I insisted on trying something else (Wellbutrin). Within 2 months I had lost the aberrant 10 pounds.

Lexapro review by 25 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Depression
Dosage & duration:		20mg taken once a day for the period of Around 2 years
Other conditions:		None
Other drugs taken:		Just Microgynon
		Reported Results
Benefits:		Placebo effects, I thought it was helping at first
Side effects:		Turned me into a zombie, incaple of feeling pleasure or any positive emotions at all.
Comments:		I took the pills for around two years then heard on the news that many anti-depressants were no more effective than placebo. I decided to stop taking them, I weaned myself off over a few weeks. After this time I was a new person, the world felt real again, I was no longer plodding through life in a daze, I was so much happier, the things I used to enjoy I started to enjoy again. I am extremely angry that I cannot get back those years that I was taking various anti-depressants that turned me into a zombie who did not care about anything or anyone. I understand everyone is different and these may work for some people, but for me these drugs ruined my life, if you are taking them you could be missing out on so much, please consider whether they are doing more harm than good!